Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020886
Company: CONCORDIA
Company: CONCORDIA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PANRETIN | ALITRETINOIN | EQ 0.1% BASE | GEL;TOPICAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
02/02/1999 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20886lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20886ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20886.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/22/2013 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/21/2000 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/12/1999 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/02/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20886lbl.pdf |